FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHSCANNER(R) PTA BALLOON DILATATION CATHETER
K Number: K902454
·
Decision Aug 30, 1990
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
15
Review Days
90
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Basic Information
- Device Name
- CATHSCANNER(R) PTA BALLOON DILATATION CATHETER
- K Number
- K902454
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Endosonics Corp.
- Date Received
- June 1, 1990
- Decision Date
- August 30, 1990
- Product Code
- LIT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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Other Clearances by Endosonics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K000820 | AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 | Jun 5, 2000 | Substantially Equivalent |
| K990271 | ENDOSONICS TRAK BACK DEVICE | Aug 30, 1999 | Substantially Equivalent |
| K982329 | VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) | Jan 14, 1999 | Substantially Equivalent |
| K965223 | RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Jun 29, 1998 | Substantially Equivalent |
| K963290 | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Aug 6, 1997 | Substantially Equivalent |
| K962293 | ENDOSONICS AUTOMATIC PULL BACK DEVICE | Sep 16, 1996 | Substantially Equivalent |
| K950276 | MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM | Sep 22, 1995 | Substantially Equivalent |
| K944004 | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) | May 4, 1995 | Substantially Equivalent |
| K926252 | CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY | Oct 25, 1993 | Substantially Equivalent |
| K924980 | CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH | Jan 15, 1993 | Substantially Equivalent |